Biopharma’s Big Inflection Point: There’s never been a better time to innovate with next-generation medicine
In all of the years I have been tracking and helping to drive biotech innovation, I can say...
The Future of Advanced Therapies: Strategies to Evolve Global Health in a Post-COVID World
How to create a smart integrated drug development plan including considerations for cell and gene therapies
An integrated drug development plan is a critical tool for the efficient and effective progression from the R&D...
Risk Management Plans for ATMPs
ATMPs are a relatively novel class of medicinal products with anew and very unique set of potential risks...
Neutralizing Antibody Assay Development – a key consideration for immunogenicity packages
Neutralising Antibodies, or NAbs, are a subclass of Anti-Drug Antibodies that may be formed during an unwanted immunogenic...
Better late than never? What developers of SARS-CoV-2 vaccines in early-to -late-stage development should consider
Unfortunately, as of today the ongoing pandemic is still far from being under control, with close to 3...